DOSING AND PHARMACOKINETICS OF INTRAVENOUS AMOXICILLIN IN CHILDRE

Recruiting

• Conditions: bacterial infectious diseases; bacterial infections; 10004018

• Registration Number: NL-OMON32761
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1. Patients who receive intravenous treatment with amoxicillin
2. Patients < 18 years
3. Written informed consent from the patient and/or their legal guardian

Exclusion Criteria

Patients with a known allergy to amoxicillin or related compounds

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters in this study will be:<br /><br>* T1/2 (half-life during elimination phase) and Vss (volume of distribution in<br /><br>steady state) of amoxicillin<br /><br>* Total body clearance, AUC (area under the time-concentration curve), MRT<br /><br>(mean residence time)<br /><br><br /><br>Interpretation of pharmacokinetic parameters<br /><br>* Plasma concentrations and the AUC*s of amoxicillin will be compared to the<br /><br>MIC (minimal inhibitory concentration) of the microbe to be eliminated.<br /><br>* T1/2 of amoxicillin will be related to the GFR (glomerular filtration)<br /><br>* All pharmacokinetic parameters will be related to the personal<br /><br>characteristics of the subjects<br /><br><br /><br>Finally, all data will lead to a new dosing advice on intravenous amoxicillin<br /><br>treatment in children.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>